来氟米特致45例不良反应的文献分析

Literature Analysis of 45 ADR Cases Induced by Lefunomide

目的:探讨来氟米特所致不良反应(ADR)的一般规律和特点,为其合理应用提供参考。方法:检索《中国期刊全文数据库》(CNKI)1994～2010年4月收载的关于来氟米特所致不良反应的文献,按患者年龄、性别、给药途径、用药剂量、ADR发生时间、累及器官/系统及临床表现、治疗与转归等进行分类统计、分析。结果:共得到文献37篇,符合标准的病例45例。女性ADR发生率(75.56%)高于男性(24.44%),50～60岁发生ADR最多,为28例。39例患者给予剂量10～30mg,qd。用药后最常见胃肠道ADR发生在1～15d。来氟米特的ADR以消化系统最多(75.56%)。用药时间短(10d内),ADR较轻的患者对症处理后减轻或消失,无需停药;但用药时间较长(10d以上),ADR较严重的患者需要立即停药,对症处理。结论:临床医师在合理应用来氟米特的同时,应密切关注其在治疗过程中的各种ADR,以减少危害。

OBJECTIVE： To investigate the characteristics and regularity of ADR cases caused by leflunomide, and to provide reference for rational use of it. METHODS： Literatures about leflunomide-inducing ADR were retrieved from CNKI between 1994 and Apr. 2010. Those literatures were statistically analyzed in respect of patient’s age and gender, route of administration, dosage of drugs, onset time of ADR, organs and systems involved in ADR and its clinical manifestations, treatment and outcomes, etc. RESULTS： 37 pieces of literatures were obtained with standard cases of 45. The incidence of ADR cases in female（75.56%） was higher than in males （24.44%）. 28 ADR cases were in 50～60 group. 39 patients were treated with leflunomide 10～30 mg once a day. After treatment, the most common gastrointestinal adverse events occurred in 1～15 d. Leflunomide-inducing ADR was digestive system reaction （75.56%） the most. Patients who took medicine less than 10 days with mild ADR need not to stop taking medicine when clinical symptoms reduced or disappeared after symptomatic treatment. Patients who took medicine more than 10 days with severe ADR need to stop taking medicine and receive symptomatic treatment. CONCLUSION： Clinical physicians should pay attention to rational use of leflunomide and ADR during treatment course to reduce the harm due to adverse events.